MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S
Device Facts
| Record ID | K010021 |
|---|---|
| Device Name | MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S |
| Applicant | Medical Components, Inc. |
| Product Code | FOZ · General Hospital |
| Decision Date | Feb 23, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5200 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.
